idursulfase 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
enzymes 4918 50936-59-9

Description:

MoleculeDescription

Synonyms:

  • idursulfase
  • iduronate-2-sulfatase
  • idursulfase (Genetical Recombination)
  • iduronate sulfatase
  • elaprase
  • EC 3.1.6.13
An enzyme that specifically cleaves the ester sulfate of iduronic acid. Its deficiency has been demonstrated in Hunter's syndrome, which is characterized by an excess of dermatan sulfate and heparan sulfate. EC 3.1.6.13.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 8, 2007 EMA Shire Human Genetic Therapies AB
July 24, 2006 FDA SHIRE

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infusion related reaction 535.74 36.27 233 5767 52824 34898107
Poor venous access 206.60 36.27 63 5937 5120 34945811
Product dose omission issue 196.84 36.27 163 5837 119548 34831383
Carpal tunnel syndrome 186.46 36.27 57 5943 4669 34946262
Inappropriate schedule of product administration 153.25 36.27 108 5892 62188 34888743
Pyrexia 152.77 36.27 232 5768 332781 34618150
Adenoidal disorder 104.68 36.27 15 5985 15 34950916
Product availability issue 97.26 36.27 28 5972 1859 34949072
Urticaria 84.02 36.27 76 5924 62301 34888630
Hydrocephalus 83.32 36.27 32 5968 5200 34945731
Respiratory disorder 81.22 36.27 47 5953 19217 34931714
Respiratory distress 81.03 36.27 59 5941 35606 34915325
Device related infection 80.60 36.27 45 5955 17192 34933739
Seizure 79.87 36.27 94 5906 104763 34846168
Complication associated with device 79.04 36.27 32 5968 5974 34944957
Central venous catheterisation 78.62 36.27 22 5978 1317 34949614
Respiratory tract infection 67.30 36.27 42 5958 19670 34931261
Adenoidal hypertrophy 66.26 36.27 13 5987 158 34950773
Ear infection 65.64 36.27 33 5967 10198 34940733
Inguinal hernia 65.28 36.27 30 5970 7611 34943320
Cough 64.59 36.27 102 5898 150038 34800893
Catheter site swelling 61.03 36.27 14 5986 372 34950559
Illness 56.98 36.27 33 5967 13496 34937435
Tonsillar hypertrophy 56.56 36.27 15 5985 733 34950198
Ear tube insertion 54.98 36.27 10 5990 78 34950853
Therapy interrupted 53.97 36.27 32 5968 13665 34937266
Cyanosis 50.76 36.27 30 5970 12734 34938197
Vascular device infection 50.64 36.27 21 5979 4164 34946767
Surgery 50.43 36.27 31 5969 14126 34936805
Bronchospasm 50.10 36.27 28 5972 10703 34940228
Umbilical hernia 48.39 36.27 21 5979 4656 34946275
Otitis media 47.28 36.27 18 5982 2854 34948077
Gastrostomy 46.67 36.27 13 5987 765 34950166
Stridor 45.78 36.27 17 5983 2517 34948414
COVID-19 45.36 36.27 61 5939 77489 34873442
Influenza 45.36 36.27 49 5951 49617 34901314
Knee deformity 43.94 36.27 12 5988 656 34950275
Crying 40.83 36.27 20 5980 5842 34945089
Infusion site extravasation 40.08 36.27 18 5982 4326 34946605
Adenoidectomy 39.21 36.27 8 5992 120 34950811
Acute kidney injury 38.26 36.27 4 5996 304984 34645947

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infusion related reaction 346.14 37.72 200 4735 230037 79509416
Product dose omission issue 171.19 37.72 133 4802 247404 79492049
Poor venous access 168.28 37.72 57 4878 18092 79721361
Pyrexia 156.70 37.72 200 4735 678509 79060944
Carpal tunnel syndrome 141.33 37.72 51 4884 19477 79719976
Inappropriate schedule of product administration 117.26 37.72 83 4852 133545 79605908
Seizure 88.00 37.72 81 4854 188753 79550700
Respiratory distress 87.89 37.72 51 4884 58288 79681165
Product availability issue 86.40 37.72 24 4911 3923 79735530
Respiratory disorder 80.53 37.72 44 4891 44812 79694641
Hydrocephalus 78.71 37.72 27 4908 8873 79730580
Device related infection 76.79 37.72 39 4896 34255 79705198
Adenoidal disorder 72.50 37.72 12 4923 158 79739295
Central venous catheterisation 72.00 37.72 20 4915 3269 79736184
Inguinal hernia 70.56 37.72 23 4912 6465 79732988
Adenoidal hypertrophy 64.16 37.72 11 4924 181 79739272
Complication associated with device 60.99 37.72 27 4908 17469 79721984
Urticaria 57.82 37.72 64 4871 185137 79554316
Cough 51.66 37.72 86 4849 366703 79372750
Cyanosis 51.63 37.72 27 4908 25155 79714298
Respiratory tract infection 51.51 37.72 34 4901 48655 79690798
Bronchospasm 49.11 37.72 26 4909 24833 79714620
Therapy interrupted 48.76 37.72 28 4907 31313 79708140
Catheter site swelling 48.58 37.72 13 4922 1847 79737606
COVID-19 46.64 37.72 53 4882 157621 79581832
Ear tube insertion 46.36 37.72 8 4927 137 79739316
Tonsillar hypertrophy 45.97 37.72 12 4923 1550 79737903
Umbilical hernia 45.02 37.72 16 4919 5829 79733624
Gastrostomy 44.13 37.72 11 4924 1182 79738271
Ear infection 43.76 37.72 27 4908 34405 79705048
Stridor 42.28 37.72 15 4920 5438 79734015
Vascular device infection 39.52 37.72 17 4918 10259 79729194
Pneumonia 39.29 37.72 109 4826 660137 79079316

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AB09 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Enzymes
FDA CS M0000794 alpha-Glucosidases
FDA EPC N0000175823 Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Mucopolysaccharidosis, MPS-II indication 70737009 DOID:12799




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
5W8JGG2651 UNII
D04499 KEGG_DRUG
4025595 VUID
N0000179797 NUI
4025595 VANDF
C1739462 UMLSCUI
CHEMBL1201826 ChEMBL_ID
DB01271 DRUGBANK_ID
8222 INN_ID
C517982 MESH_SUPPLEMENTAL_RECORD_UI
644101 RXNORM
21811 MMSL
84277 MMSL
d05855 MMSL
011684 NDDF
424323009 SNOMEDCT_US
84524005 SNOMEDCT_US
D007066 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ELAPRASE HUMAN PRESCRIPTION DRUG LABEL 1 54092-700 SOLUTION, CONCENTRATE 6 mg INTRAVENOUS BLA 25 sections
ELAPRASE HUMAN PRESCRIPTION DRUG LABEL 1 54092-700 SOLUTION, CONCENTRATE 6 mg INTRAVENOUS BLA 25 sections